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Behavioural Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS) for Neuropathic Pain

N/A

Waitlist Available

Led By Chantel T Debert, MD MSc FRCPC

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neuropathic pain for at least 3 months, as diagnosed by a physician

Physician-diagnosed spinal cord injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment.

Awards & highlights

Study Summary

"This trial will investigate whether a type of brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can help reduce pain in adults with neuropathic pain after a spinal cord injury."

Who is the study for?

This trial is for adults aged 18-75 with neuropathic pain lasting at least 3 months due to a spinal cord injury. Candidates must not have other conditions causing the pain, no prior TMS therapy, and no contraindications like pacemakers, metal implants in the head, seizures, severe psychiatric disorders, or uncontrolled major diseases.Check my eligibility

What is being tested?

The study tests whether repetitive Transcranial Magnetic Stimulation (rTMS) can relieve neuropathic pain in individuals who've suffered a spinal cord injury. rTMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain.See study design

What are the potential side effects?

Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms of facial muscles. Rarely it may cause seizures or hearing loss if ear protection isn't used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with nerve pain for at least 3 months.

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I have a spinal cord injury diagnosed by a doctor.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) v3.0

Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a

Secondary outcome measures

Generalized Anxiety Disorder scale-7 (GAD-7)

Pain Catastrophizing Scale (PCS)

Patient Health Questionnaire-9 (PHQ-9)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment1 Intervention

Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Treatment intensity will be applied at 100-120% of the participant's resting motor threshold. The neurostimulation protocol will be 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with inter-train interval of 45-seconds. The rTMS will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36) on a standardized brain. Participants will be seated in a comfortable chair or their wheelchair for each rTMS session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation (rTMS)

2019

Completed Phase 2

~780

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,144 Total Patients Enrolled

2 Trials studying Neuropathic Pain

132 Patients Enrolled for Neuropathic Pain

Chantel T Debert, MD MSc FRCPCPrincipal InvestigatorUniversity of Calgary

1 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include individuals aged 40 and above?

"The trial is seeking individuals aged 18 years and older but not exceeding 75 years in age."

Answered by AI

Which individuals are eligible to take part in this clinical study?

"Individuals aged between 18 and 75 experiencing neuropathic pain are sought for this investigation, with a specific target of enrolling 10 participants."

Answered by AI

Is the process of enrolling participants currently underway for this clinical trial?

"Data from clinicaltrials.gov shows that this particular study is not actively seeking participants. Originally shared on 5/1/2024, and last updated on 2/21/2024; although recruitment for this trial has closed, there are currently 474 other studies open to enrollment."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The main objective of this investigation is to evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a. To gauge this, assessments will be conducted at baseline, after rTMS treatment (1-month), and post-treatment at 1-month and 3-months intervals. Secondary endpoints include evaluating health and disability using the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 tool, assessing anxiety levels with the Generalized Anxiety Disorder scale-7 (GAD-7), and examining depression severity utilizing the Patient Health Questionnaire-9 (PH"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach

2024. "Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06284694.

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